1. Field of the Invention
Present invention relates to a bioactive fluid ejection cartridge and system for manufacturing pharmaceutical doses. More particularly the present invention relates to a bioactive fluid ejection cartridge and system for manufacturing pharmaceutical doses on an ingestible sheet.
2. Description of the Art
Oral administration of pharmaceuticals is one of the most widely used methods to provide effective therapy for a variety of illnesses. Many powdered medications are typically administered orally to a person in a dosage form such as either tablets or capsules, while still others are in liquid form. The release of orally administered medications falls into two broad categories, buccal or sublingual administration, and oral dissolution. For example, enteric coated tablets that release the medication in the intestinal tract of the patient. Most pharmaceuticals involve dosage units in the microgram to milligram range of the purified active ingredient or ingredients. Thus, many pharmaceutical doses in tablet or liquid form are made in formulations of a predetermined quantity of pharmaceutical units in each dose. Such pharmaceutical doses are frequently available in fixed different strengths, such as 50 mg, 100 mg, etc. Unfortunately, such conventional oral dosage forms suffer from a number of disadvantages.
In order to effectively handle and dispense such small dosage units typical methods for manufacturing include mixing a known amount of the pure drug into various solid and/or liquid substances commonly referred to as excipients or diluents. In addition, other materials such as binders, lubricants, disintegrants, stabilizers, buffers, preservatives etc. are also mixed with the pure ingredient.
Although these materials are therapeutically inert, non-toxic, and play an important role in the manufacture of pharmaceuticals, their use nonetheless presents problems. For example, the use of diluents typically involves sequential dilutions, each of which can increase variability. In addition, through mixing requires complicated routines and apparatus to assure that uniform doses are produced. Further, the processing generates heat, which can be destructive to certain active ingredients. Thus, the mixing apparatus may need to be cooled or production slowed to prevent excessive heat. Hot spots in the mixing apparatus can also contribute to variability in the doses produced. Thus, tight control over the various dilutions, mixings, and on tool settings are required to maintain adequate control over the accuracy and precision of the doses by typical manufacturing processes.
These therapeutically inactive materials also have the disadvantage that each such material must be evaluated before use in terms of potential incompatibilities with the medicaments present. For example, some of these materials such as lubricants or disintegrants may present problems concerning the bioavailability of the active ingredient. Further, the certification of new drugs is a lengthy and costly process involving animal studies followed by chemical trials to establish both the efficacy and safety of the new drug. Because a pharmaceutical""s characteristics may be affected by changes in manufacturing and/or packaging, the approval process limits the approval to a particular manufacturing and packaging process. Thus, the ability to rapidly and easily change dosage units is extremely limited in conventional pharmaceutical manufacturing systems and processes.
The batch concept is also a disadvantage from the viewpoint of the economics of the batch designation, control and evaluation. This is especially true for solid oral unit dosage forms, where typical assay methods involve the destruction of the dosage form, resulting in a limited number of such forms being tested compared to the total number of forms actually produced. Thus, there can be a considerable deviation within a given batch since the mean dosage for each batch is determined by the analysis of a relatively small number of samples.
Drugs with a narrow therapeutic range must also be precisely dosed. If the patient falls below the range, the desired effect will not occur. However, if the patient is above the range then the risk of toxic effects increases. Clinicians assume the dose units manufactured are uniform and that generic equivalents have equal bioavailability. The many FDA generic formulation rejections and recalls for pharmaceuticals that have too high or low of a drug level, however, are evidence that accuracy and precision are still challenges for pharmaceutical manufacturing.
Thus, the ability to reduce the number of therapeutically inactive materials, the number of dilutions, and the number of mixings in the manufacture of unit dosage forms would be desirable. In addition, an apparatus and system that provides for the custom dispensing of pharmaceutical unit dosage forms where the type of pharmaceutical, and the quantity of the selected drug can be easily varied to meet a specific prescription would also be desirable. It would also be desirable to provide an apparatus and system that is capable of dispensing multiple, different pharmaceuticals in varied, selected quantities to a single receiving medium thus simplifying the taking of drugs, especially combinations of different drugs by providing multiple drugs in one dose.
A fluid ejection cartridge for dispensing a bioactive fluid including a first reservoir containing the bioactive fluid and a first fluid ejector fluidically coupled to the first reservoir. The first fluid ejector ejects at least a drop of the bioactive fluid onto the ingestible sheet.